Fueled by increasing investor interest, the pharma life sciences industry has seen a significant increase in Merger and Acquisition activities as companies seek to supplement their Research and Development capabilities or add additional products to their portfolio. When companies acquire a new asset, navigating the global regulatory landscape and conducting Marketing Authorization (MA) updates can be an overwhelming and tricky endeavor with multitude of cross-functional dependencies with Quality Assurance, Labeling, Commercial, Supply Chain, Finance, Human Resources (HR), and Information Technology (IT).
Regulatory is the backbone a dynamic plan of action in conjunction with other related dependencies to ensure business continuity and overall successful integration. Establishing a dynamic plan enabled by emerging digital technology well ahead of regional execution is a key step in mitigating delays in MA transfers and ensuring supply continuity in regional/ local markets.
Identify advantages to starting a regulatory transition plan far in advance of commencement of Integration Activities.
Identify regulatory-related tasks and interdependencies.
Apply a dynamic framework to future merger and acquisition and successful regulatory functional integration.